Experts urge holding off on hazardous H5N1 studies

Jul 27, 2012 (CIDRAP News) – As leading influenza researchers prepare to meet in New York City next week, several eminent life-sciences authorities are calling for continuation of a moratorium on studies involving lab-modified H5N1 viruses with increased transmissibility, according to a story today in the British newspaper The Independent.

The veteran researchers assert that lifting the moratorium now would be a mistake because it would increase the risk of an accidental release of a deadly virus. Among them are Stanley Plotkin, MD, who played key roles in the development of several important vaccines, and Paul Berg, PhD, and Stanley Falkow, PhD, who helped organize the 1975 Asilomar conference, which led to guidelines on recombinant DNA research.

The scientists essentially say the moratorium should remain in place until the risks of the research and proposed precautions can be thoroughly examined in an open process, not one limited to flu researchers.

"History is full of incidents of escape of microorganisms from laboratories, and scientists are not always good at risk evaluation," Plotkin told the newspaper.

The moratorium was declared by leading flu researchers in January, amid the controversy over proposed publication of two studies involving lab-modified H5N1 viruses with airborne transmissibility in ferrets, which raised concern about the risk of deliberate or accidental release of a virus that could spark a human flu pandemic. Originally the moratorium was to last 60 days, but it has now continued for more than 6 months, and it's not clear how or when it will end.

The US National Science Advisory Board for Biosecurity (NSABB) recommended late last year that key details of the two studies be stripped out before publication. But after learning more about the studies, the board reversed its decision on Mar 30, though the panel split on one of the studies. The full studies were published in May and June, one in Nature and the other in Science.

Possible steps toward ending the moratorium are expected to be discussed in New York next week at the annual conference of the Centers of Excellence for Influenza Research and Surveillance (CEIRS). The network includes five academic centers, all funded by the US National Institute of Allergy and Infectious Diseases (NIAID). (One of the CEIRS groups is based at the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News.)

Plotkin, an emeritus pediatrics professor at the University of Pennsylvania and author of a standard textbook on vaccines, told the Independent that creating an H5N1 strains with airborne transmissibility would be like creating anthrax bacteria that could spread from person to person.

Berg said lifting the moratorium would be "a bit ludicrous" because there is no scientific rationale for doing so, according to the story. "There should be a serious review and evaluation of the concerns that led to the moratorium and a scientifically rigorous analysis of why the concerns can be managed before the moratorium could be lifted," he said.

Berg is a Nobel prize winner in chemistry and professor emeritus of molecular and genetic medicine at Stanford University.

Falkow, a professor of microbiology and immunology at Stanford, told the paper, "The moratorium is essential until such time as there is a dispassionate international meeting to address the issues brought to the fore by the H5N1 affair."

Joining them in calling for a continued hold on the research was Richard J. Roberts, PhD, a Nobel prize-winning molecular biologist who now works for New England Biolabs in Ipswich, Mass.. He said many experts privately oppose lifting the ban but are afraid of speaking out for fear that it might affect their funding from the National Institutes of Health, according to the story.

"It's a big mistake at this point," he said. "The flu community is behaving as if they are the only show in town. I think for them to be allowed to create the most dangerous virus around is sheer lunacy."

"I'm not so much worried about terrorism but I am worried about an accidental escape from a laboratory. If it's as dangerous as they believe, it could kill half the world's population," Roberts added.

Also quoted in the story was David Relman, MD, an NSABB member and professor of medicine and infectious diseases at Stanford. He voted against full publication of one of the two studies, the one led by Ron Fouchier, PhD, of Erasmus University in the Netherlands. Relman called for a broad international discussion to consider the risks and benefits of the research.

NIAID Director Anthony Fauci, MD, is scheduled to attend the CEIRS meeting and lead a discussion on "The Way Forward in Influenza Research" on Jul 31. NIAID officials today declined to comment on the Independent story. Yoshihiro Kawaoka, DVM, PhD, lead author of the other controversial H5N1 study, did not respond to an e-mail request for comments today.

Adolfo Garcia-Sastre, PhD, director of the CEIRS center at Mt. Sinai School of Medicine in New York City, said this week that he doesn't think that a decision about lifting the moratorium will come out of the CEIRS meeting, according to media reports.

"A decision about lifting the moratorium? No. A decision about what it requires to lift the moratorium? Maybe," he told the Canadian Press (CP).

Garcia-Sastre noted that researchers are waiting for policy decisions by the federal government before they can resume government-funded research, including a ruling on what level of biosafety will be required, according to the CP story.